Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy - Full Text View

Sponsor:	Duke University
Collaborator:	Merck
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00734929

Purpose

We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: Aprepitant + Dexamethasone Drug: Ondansetron + Dexamethasone	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Ondansetron hydrochloride Ondansetron Aprepitant Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

cumulative incidence of emesis [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of nausea [ Time Frame: PACU ] [ Designated as safety issue: No ]
Incidence of nausea [ Time Frame: 24 h ] [ Designated as safety issue: No ]
Incidence if nausea [ Time Frame: 48 h ] [ Designated as safety issue: No ]
Incidence of vomiting [ Time Frame: PACU ] [ Designated as safety issue: No ]
Incidence of vomiting [ Time Frame: 24 h ] [ Designated as safety issue: No ]
Use of rescue antiemetics [ Time Frame: PACU ] [ Designated as safety issue: No ]
Use of rescue antiemetics [ Time Frame: 24 h ] [ Designated as safety issue: No ]
Use of rescue antiemetics [ Time Frame: 48 h ] [ Designated as safety issue: No ]
Complete response rate [ Time Frame: PACU, 24 h, 48 h ] [ Designated as safety issue: No ]
Nausea scores [ Time Frame: PACU, 24 h, 48 h ] [ Designated as safety issue: No ]
number of vomiting episodes [ Time Frame: 48 h ] [ Designated as safety issue: No ]
Time to first vomiting [ Time Frame: 48 h ] [ Designated as safety issue: No ]
Patient satisfaction [ Time Frame: 48 h ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Aprepitant + dexamethasone	Drug: Aprepitant + Dexamethasone Aprepitant 40 mg + Dexamethasone 10 mg
2: Active Comparator Ondansetron + Dexamethasone	Drug: Ondansetron + Dexamethasone Ondansetron 4 mg + Dexamethasone 10 mg

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A patient is eligible for inclusion in this study if all of the following criteria apply:

Age: 18-75 years of age
Surgery: craniotomy under general anesthesia.
ASA Status: ASA: I, II, or III
Language: Fluent in the English language
Informed Consent: Written informed consent must be obtained.

Exclusion Criteria:

A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:

Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
Nausea verbal rating score (VRS): A VRS nausea score > 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734929

Contacts

Contact: Magdi A ElGasim, MD	919 681 2217	mike.elgasim@duke.edu
Contact: Leonida Balajonda, MD	919 681 4377	narai.balajonda@duke.edu

Locations

United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Ashraf S Habib, MBBCh, FRCA 919-668-6266 habib001@mc.duke.edu
Contact: Mike A ElGasim, MD 919 681 2217 mike.elgasim@duke.edu
Principal Investigator: Ashraf S Habib, MBBCh

Sponsors and Collaborators

Duke University

Merck

Investigators

Principal Investigator:

Ashraf S Habib, MBBCH, FRCA

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center ( Ashraf Habib )
Study ID Numbers:	1404
Study First Received:	August 13, 2008
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00734929 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

PONV
nausea
emesis
antiemetics

aprepitant
ondansetron
dexamethasone

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Neurotransmitter Agents
Vomiting
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes

Therapeutic Uses
Antipruritics
Nausea
Ondansetron
Dermatologic Agents
Dexamethasone acetate
Aprepitant
Postoperative Nausea and Vomiting
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010